- UK-based pharma AstraZeneca plc released its year-to-date results in an early morning call Thursday. Products sales were $14.7 billion year-to-date, a 9% drop year-on-year, driven by U.S. patent expiries for Crestor, Nexium and Seroquel.
- AstraZeneca's 'growth platforms' grew by 3%, making up two thirds of the company's total revenue. Breaking these up, emerging markets grew by 5%, including a 12 % growth in China; 'New CVMD' grew by 5%, driven by Brilinta and Farxiga; 'New Oncology' grew by 96%, driven by Tagrisso and Lynparza; and Japan grew by 3%. Respiratory fell by 5%, with Symbicort pressure in the U.S.
- AstraZeneca anticipates a 2017 core EPS performance towards the favorable end of the guidance range of a low to mid-teens percentage decline. The company still expects a low to mid-single digit percentage decline in revenues for the year.
AstraZeneca has been fighting back against a decline in sales and R&D productivity, and has spent the last decade restructuring, cutting and reshaping to create a company with three key areas of focus – oncology, respiratory and cardiovascular and metabolic diseases (CVMD). While sales are likely to continue to be affected by patent losses into 2018, with the last Crestor (rosuvastatin) expiry in Europe next year, CEO Pascal Soriot expects to see a return to growth as the patent losses recede and as drugs from the growing R&D pipeline reach the market.
"While we have seen some setbacks, we are focusing on the science to meet unmet needs, and we are rapidly gaining momentum in the launch of new products – we are currently in the midst of seven launches, and have had five products reimbursed in China," he said.
"The third quarter of 2017 has delivered a quite unprecedented news flow, including four new medicines approved to date, and our first approval of a drug in blood cancer. We expect to see a lot of regulatory submissions and decisions before the end of 2018, and a lot of growth drivers coming on stream," added Soriot on the Nov. 9 call.
The BTK inhibitor Calquence (acalabrutinib), had breakthrough therapy designation in the U.S. and received approval from the Food and Drug Administration earlier this month for the second-line treatment of mantle cell lymphoma (MCL). AstraZeneca acquired Calquence when it took a multi-billion dollar majority equity stake in Acerta Pharma in February 2016.
"Calquence will be the cornerstone of our presence on hematology," said Soriot. "Hematology was always going to be one of our areas of focus, but it wasn't where we had capabilities. So our first step was in partnership with Acerta. Calquence addressed an area of unmet need, and through our investment we acquired not only a product but a great team. Acerta has become our center of excellence in San Francisco, and we are moving products from preclinical in Cambridge (UK) to early clinical trials in San Francisco."
Calquence is also in Phase 3 development for other B-cell malignancies, and for first-line treatment of chronic lymphocytic leukemia, relapsed/refractory CLL, and first line MCL.
AstraZeneca is looking to broaden its oncology portfolio, based on new platforms, such as the antibody-drug technology behind moxetumomab pasudotox, another hematology drug. Moxetumomab pasudotox has completed a Phase 3 trial in relapsed and/or refractory hairy cell leukemia. Moxetumomab pasudotox came to AstraZeneca via its acquisition of Cambridge Antibody Technology, and AstraZeneca plans a filing in the first half of 2018.
"Moxetumomab pasudotox is an effective therapy and will meet a small unmet medical need. It fits in with Calquence in hematology, and is based on a platform that is in expansion," said CMO Sean Bohen. "We need to have a robust platform in order to sustain our return to growth."
And closing on a Brexit note, which is especially a concern for UK-based companies. AstraZeneca is working to prepare for the potential eventuality of a 'hard' Brexit.
"We have a team of people working to avoid an interruption in the supply chain. Some of our products cross borders a number of times We are duplicating QA and release process in the UK and Europe, and we may have to recruit people in other sites outside the UK. We have no choice – we have to have a contingency plan in case of a hard Brexit," said Soriot.
Correction: A previous version of this article incorrectly identified the disease indication for the Phase 3 study of moxetumomab pasudotox.